Ipsum Clinical and Fundación Salud para el Trópico (Tropical Health Foundation) were awarded GCP certification by INVIMA for its clinical research center located in the village Calabazo in the Sierra Nevada of Santa Marta. Certification in GCP is a requirement for conducting clinical trials in Colombia. Having a unique center like this increases the ability […] [...]

The goal is to position the country as the top destination in Latin America to conduct clinical research for the biopharma and medical device industry. Miami, FL, May 30, 2015 ΓÇô Procolombia, ColombiaΓÇÖs exports, tourism, investment, and country brand agency, signed an alliance in 2014 with Interventional Concepts, Inc. (ICI) ΓÇöa leading clinical development firm […] [...]

Most of our attention is focused on medical device regulations in Europe and Asia. But Latin American countries are also hard at work to update their regulations. Two bits of news out of Colombia today. First, according to┬áEmergo Group, is an INVIMA (ColombiaΓÇÖs medical device regulator) communication that specifies that ΓÇ£registration materials pertaining to biocompatibility, […] [...]

Colombian medical device regulator INVIMA has eased some translation and grouping criteria for market registrants. According to an┬áINVIMA communication, Colombia registration materials pertaining to biocompatibility, risk analysis, sterilization, and clinical studies and test reports may now be submitted to reviewers in their language of origin; summaries of study descriptions, methods and conclusions must be provided […] [...]

In a clinical trial that could lead to treatments that preventAlzheimerΓÇÖs, people who are genetically guaranteed to develop the disease ΓÇö but who do not yet have any symptoms ΓÇö will for the first time be given a drug intended to stop it, federal officials announced Tuesday. Experts say the study will be one of […] [...]

Latin American (LA) countries operate increasingly in accordance with international standards and guidelines. This has been a major driver for increasing interest and placement of clinical studies in the region. Even though LA countries are considered to have many similarities, it is important to keep in mind that, in reality, they are 20 different countries, […] [...]

With a focus on capacity building and empowering, we assist health care firms in the development of their products, by formulating, setting-up and managing clinical trials, in ways that ensure customers satisfaction, to in the last term, facilitate the access of innovative products to the market.